Effect of Intravenous Vitamin C Supplementation on the Quality of Sleep, Itching,Restlessleg Syndrome in Patients Undergoing Hemodialysis In Tohid Hospital in Sanandaj at 2016
The purpose of this study was to determine the effect of intravenous vitamin C on sleep quality, Itching and Restless leg Syndrome in hemodialysis patients.
Design
Double-blind clinical trial with two parallel arm
Settings and conduct
This study was performed on chronic renal failure patients undergoing dialysis in Sanandaj Tohid Hospital in double blinded two arm design, by using the same method of packaging and drug delivery and package coding. Patients arriving after Signed Consent Consciously, an envelope will be selected from the envelope containing the code, and the will receive the medicine by same code .
Participants/Inclusion and exclusion criteria
inclusion: Patients with low sleep quality (score less than 5 based on global scores) Kidney failure, dialysis for at least 6 months, signing Informed consent, dialysis at least 3 times a week. Insomnia and or itching and or restless leg syndrome
Exclusion : kidney transplantation and returned to hemodialysis.
Dissatisfaction with the company in the study
Failure to cooperate in completing the questionnaire
People who have recived vitamins C, E, or fish oil during the two months before the study
history of mental illness, severe heart and respiratory disease, or history of infectious disease three months before the study began.
Taking immunosuppressive drugs in the last two months.
Intervention groups
intervention group received a 5-cc (500 milligram) vial of vitamin C from the Daropakhsh company
control group, 5 cc normal saline was given as a placebo for injection three times a week at the end of each dialysis session and intravenously for eight weeks.
Main outcome variables
Itching, sleep Quality, Restless leg syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141208020249N4
Registration date:2018-12-05, 1397/09/14
Registration timing:retrospective
Last update:2018-12-05, 1397/09/14
Update count:0
Registration date
2018-12-05, 1397/09/14
Registrant information
Name
Behzad Khalafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 9697
Email address
khalafi.behzad70@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-02, 1394/01/13
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
2015-04-19, 1394/01/30
Actual recruitment end date
2016-07-20, 1395/04/30
Trial completion date
2016-09-20, 1395/06/30
Scientific title
Effect of Intravenous Vitamin C Supplementation on the Quality of Sleep, Itching,Restlessleg Syndrome in Patients Undergoing Hemodialysis In Tohid Hospital in Sanandaj at 2016
Public title
Intravenous Vitamin C Supplementation on the Quality of Sleep, Itching,Restlessleg Syndrome in Patients Undergoing Hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with low sleep quality (score less than 5 based on global scores)
Kidney failure, which has been dialyzed for at least 6 months
signing Informed consent
Kidney failure, which is dialyzed at least 3 times a week.
Insomnia and or itching and or restless leg syndrome
18 to 70 years old
Exclusion criteria:
Dissatisfaction with the company in the study
Failure to cooperate in completing the Petersburg quality of sleep questionnaire
People who have recived vitamins C, E, or multi-vitamins containing vitamin C, E or fish oil during the two months before the study
A history of mental illness, severe heart and respiratory disease, or a history of infectious disease three months before the study began.
Taking immunosuppressive drugs in the last two months.
Patients who have undergone kidney transplantation and returned to hemodialysis.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Prior to the commencement of the study, the code of medication prepared pre-prepared by a pharmacist outside the study is placed in the envelope, and the patient chooses to choose one of the envelopes upon signing the consent after signing consent. The medication code will not be delivered to the executive team until the completion of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs and placebo are packaged and coded by a pharmacist outside the study in similar containers and in similar sizes. The drug code is not provided to the researcher until the end of the study and the start of the analyzes. The patient researcher and clinical evaluator were also blinded of the contents of the drug containers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
pasdaran Blvd, opposite Shadi Hotel, Kurdistan University of Medical Sciences, Sanandaj, Management of Medical Researches and Information. POB 6617713446
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2016-04-08, 1395/01/20
Ethics committee reference number
IR.MUK.REC.1395.14
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
2
Description of health condition studied
restless leg syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
3
Description of health condition studied
Sleep Quality
ICD-10 code
G47.00
ICD-10 code description
Insomnia, unspecified
Primary outcomes
1
Description
itching
Timepoint
At the start of the study and after 8 weeks receiving the drug
Method of measurement
Level of itching according to VAS criteria
2
Description
restless leg syndrome
Timepoint
At the start of the study and after 8 weeks receiving the drug
Method of measurement
history taking and Clinical Evaluation
3
Description
Sleep Quality
Timepoint
At the start of the study and after 8 weeks receiving the drug
Intervention group: People who need dialysis which referring to dialysis department of Sanandaj Tohid Medical CenterThe intervention group received a 5-cc (500 milligram) vial of vitamin C from the Daropakhsh company
Category
Rehabilitation
2
Description
Control group: People who need dialysis which referring to dialysis department of Sanandaj Tohid Medical Center. In the control group, 5 cc normal saline was given as a placebo for injection three times a week at the end of each dialysis session and intravenously for eight weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Shahdak Dadashpour
Street address
Gheriashan St, Tohid Hospital, Department of Internal Medicine
City
Sanandaj
Province
Kurdistan
Postal code
000000000000
Phone
+98 87 3366 4645
Email
shahdakdadashpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Sanandaj, Kurdistan University of Medical Sciences, opposite Shadi Hotel, Kurdistan University of Medical Science, POB 6617713446 Management of medical research and information
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
ebrahimghaderi@yahoo.com
Grant name
Grant code / Reference number
1395.14
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Minoo sadat Hajmiri
Position
Internalist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Kurdistan University of Medical Science
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
008733664645
Email
ehaj@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shadak Dadashpour
Position
Adult Nephrologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Kurdistan University of Medical Science
City
Sannadj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
shahdakdadashpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Associate / Researcher Soldier - General Physician of Kurdistan University of Medical Scien
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kurdistan University of Medical Sciences Vice Chancellor in Research Affair Pasdaran Ave. Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 45 3344 9697
Fax
+98 87 3366 4645
Email
khalafi.behzad70@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
Shahdak Dadashpour - Tohid Hospital - Kurdistan University of Medical Science
What processes are involved for a request to access data/document
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given.